NCT03501199

Brief Summary

The investigators will use two types of material(PRF-Xenograft) in the buccal gap after immediate dental implant placement. The study design has three groups PRF, graft, and control group. The patients will randomly be assigned to groups by envelop method. The resonance frequency analysis device(Osstell) will be used to measure primary and secondary stabilization. Then the investigators will evaluate each materials' contribution to stability. Pre-op and 9th month Post-op CBCTs will evaluate about bone loss in mesial-distal and horizontal dimensions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
Last Updated

March 5, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

March 23, 2018

Last Update Submit

March 4, 2019

Conditions

Dental Implant Failure Nos

Keywords

immediate implant placement

Outcome Measures

Primary Outcomes (1)

  • Primer Stabilization-Resonance Frequency Analysis

    initial measurement after placement by Osstell device

    at 0 day

Secondary Outcomes (2)

  • Seconder Stabilization-Resonance Frequency Analysis

    120th day

  • Mesial-Distal and Horizontal Bone Loss

    9th month

Study Arms (3)

PRF Group

EXPERIMENTAL

PRF is will be used in immediate dental implant placement.

Other: platelet-rich fibrin placementProcedure: tooth extractionProcedure: immediate implant placementOther: collagen membran placementProcedure: raising flap

Graft Group

EXPERIMENTAL

The xenogenic graft is will be used in immediate dental implant placement.

Other: xenogenic graft placementProcedure: tooth extractionProcedure: immediate implant placementOther: collagen membran placementProcedure: raising flap

Control Group

EXPERIMENTAL

No extra material is will be used in immediate dental implant placement.

Other: no extra materialProcedure: tooth extractionProcedure: immediate implant placementOther: collagen membran placementProcedure: raising flap

Interventions

platelet-rich fibrin placementOTHER

filling the buccal gap with platelet-rich fibrin after immediate dental implant placement

PRF Group
xenogenic graft placementOTHER

filling the buccal gap with xenogenic graft after immediate dental implant placement

Graft Group
no extra materialOTHER

filling the buccal gap with no material after immediate dental implant placement

Control Group
tooth extractionPROCEDURE

extraction of tooth which is unrestorable

Control GroupGraft GroupPRF Group
immediate implant placementPROCEDURE

putting dental implant into a socket which has been prepared with compatible drills

Control GroupGraft GroupPRF Group
collagen membran placementOTHER

placing collagen membran on extraction socket after dental implant placement to cover all

Control GroupGraft GroupPRF Group
raising flapPROCEDURE

raising the buccal flap with two vertical incision to cover extraction socket for primary closure

Control GroupGraft GroupPRF Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • medically healthy,
  • only one maxillary aesthetic region(incisors or premolars) tooth which has two adjacent teeth is indicated for extraction.
  • intact buccal socket walls
  • the gap between buccal socket wall to implant sholder at least 2 mm.

You may not qualify if:

  • relevant tooth has more than one root,
  • smoking,
  • alcohol abuse,
  • pregnancy,
  • immune-suppressive patients,
  • any systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University, Faculty of dentistry

Konya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Alparslan Esen

    Consultant

    STUDY CHAIR

  • Gökhan Gürses

    Care Provider

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 18, 2018

Study Start

March 1, 2018

Primary Completion

May 31, 2018

Study Completion

March 4, 2019

Last Updated

March 5, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)